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GW Pharmaceuticals plc : Sativex Approval in Sweden

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12/22/2011 | 02:31am EDT

Sativex® approved in Sweden for the treatment of spasticity due to Multiple Sclerosis (MS)

Porton Down, UK; 22nd December 2011: GW Pharmaceuticals plc (AIM:GWP) today announced that the Medical Products Agency in Sweden has granted regulatory approval for Sativex® (Delta-9-Tetrahydro-cannabinol (THC) and Cannabidiol (CBD)) oromucosal spray as a treatment of moderate to severe spasticity due to MS in patients who have not responded adequately to other anti-spasticity medicationi. Sativex® is a first in class endocannabinoid system modulator and is currently available in the UK, Germany, Spain and Denmark.

Evidence generated from clinical trials shows that Sativex® has a positive impact on spasticity in multiple sclerosis, while alleviating associated symptoms including pain, bladder or sleep disturbance. By relieving the symptoms of MS, Sativex® can improve patients' quality of life and allow them greater independence in performing their daily activitiesii.

The launch of Sativex® in Sweden is expected to take place during the first half of 2012 following completion of the national pricing and reimbursement process. Sativex® will be marketed in Sweden by GW's marketing partner, Almirall S.A.

Justin Gover, GW's Managing Director, said, "We are very pleased to announce the approval of Sativex® in Sweden. Sativex® addresses a significant unmet need for people with multiple sclerosis and we look forward to the launch of this important medicine in Sweden next year."

Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).

Notes to Editors
Sativex® was developed by UK-based GW Pharmaceuticals plc in specific response to the MS population's unmet need for a prescription cannabis-based medicine. Manufactured under Home Office licence at an undisclosed location in the UK it is marketed in Europe (except the UK) by Almirall.

Sativex® is indicated as treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. Sativex® is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue) and has a flexible dosing regime, particularly appropriate given the variable nature of both spasticity and multiple sclerosis from patient to patient.

Sativex® contains active ingredients called 'cannabinoids', which are extracted from cannabis plants grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that occur naturally throughout our bodies, including in our brainsiii.  A receptor is a site on a brain cell where certain substances can stick or "bind" for a while. If this happens, it has an effect on the cell and the nerve impulses it produces, which causes a 'dimming down' of the symptoms of spasticity. In patients who respond to Sativex®, it is this effect which helps to improve their symptoms of spasticity and to help them cope better with their usual daily activitiesiv.

There are almost 500,000 people suffering of MS in the top five EU countriesv. Spasticity (otherwise known as muscle stiffness) is one of the most common symptoms of MS, occurring in as many as 75% of people with MS and has a negative impact on patients' daily lives as it reduces their capacity to carry out everyday activities such as walking, keeping upright, as well as having an impact on their general mobility, bladder function, and quality of sleepvi. This means patients have to modify or give up certain activities and often require help from a family member or carer. About half of people with MS do not manage to find relief from these symptoms with currently available treatments.

GW Pharmaceuticals
GW Pharmaceuticals plc (AIM:GWP) was founded in 1998 and is listed on the AiM, a market of the London Stock Exchange. Operating under licence from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular MS and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW's products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals.


vi. Prevalence and treatment of spasticity reported by multiple sclerosis patients - MA Rizzo et al - Multiple Sclerosis 2004; 10:589-595.

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Justin D. Gover Chief Executive Officer & Executive Director
Geoffrey William Guy Chairman
Christopher John Tovey Chief Operating Officer
Scott M. Giacobello CFO & Principal Accounting Officer
Volker Knappertz Chief Medical Officer
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